Home NDC 29978-129 Histanaz
Product NDC 29978-129
11-digit product format 299780129
Labeler code 29978
Product ID 29978-129_5013a487-2901-ef02-e063-6394a90a2902
Type HUMAN OTC DRUG
Nonproprietary name Pseudoephedrine HCL, Pyrilamine Maleate
Dosage form TABLET
Route ORAL
Labeler Capital Pharmaceutical, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-09-08
Substance PSEUDOEPHEDRINE HYDROCHLORIDE; PYRILAMINE MALEATE
Active strength 60; 30 mg/1; mg/1
Pharmacologic classes Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Histanaz
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1 PYRILAMINE MALEATE 30 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6V9V2RYJ8N Internal UNII lookup R35D29L3ZA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2727351 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 29978-129-10 Histanaz 100 in 1 BOTTLE TABLET 100 2
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 98 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 29978-129-10 29978012910 100 TABLET in 1 BOTTLE (29978-129-10) 100 tablet 2025-09-08 No No Current